Dr M. N. Dauramanzi, Zimbabwe

Blood and blood products are largely the responsibility of the National Blood Transfusion Service (BTS) of Zimbabwe, which operates as an independent organization under the Companies Act. Zimbabwe does not manufacture plasma-derived medicinal products. Almost all human blood products are imported by the BTS from South Africa, the manufacturer of these products.

The BTS has developed a quality policy and procedures manual, which was adapted from materials provided by the International Federation of Red Cross and Red Crescent Societies. World Health Organization guidelines, and the guidelines of other recognized international organizations, are also used.

Normally, the products that are accepted into Zimbabwe are registered by the South African drug regulatory authorities. All issues are computerized to facilitate a recall, should that eventuality occur. The few plasma-derived medicinal products that are processed through the Medicines Control Authority of Zimbabwe for registration before marketing must undergo an evaluation process. However, these products are not subject to laboratory analysis during the evaluation process, due to lack of expertise in analysing biological and biotechnology products.

It is suggested that WHO encourage regulatory authorities to set up a unit of specially-trained personnel to deal with the issue of biologicals and biotechnology products. WHO should sponsor training programmes, so that the quality and safety of plasma-derived products can be assured at the national level. Plasma derived products are generally very expensive to import, with resultant cost problems associated with sampling and preparing them for tests.